Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with recurrence of SBP
研究概览
简要总结
The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis and ascites.
详细描述
This study will be carried out on 100 patients with liver cirrhosis and ascites who will be enrolled from Tanta University, Tropical Medicine Department in the period between January 2014 to 6 months. The selected patients will be randomly assigned to receive 400 mg of norfloxacin daily or 1200 mg of rifaximin daily and will be classified into two groups :
Group 1 : 50 patients will be treated with 1200 mg of rifaximin daily. Group 2 : 50 patients will be treated with 400 mg of norfloxacin daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous episode of SBP
- •Total protein in the ascitic fluid below or equal to 1.5 g/dL
排除标准
- •Allergy to quinolones
- •Antibiotic therapy in the 2 weeks preceding inclusion
- •Recent ( within the previous 2 weeks) episode of digestive hemorrhage
- •Hepatocellular carcinoma or other neoplasias able to shorten life expectancy
- •Pregnant and lactating women
研究组 & 干预措施
rifaximin
Arm 1: 109 patients will be treated with 1200 mg of rifaximin daily for 6 months.
干预措施: Rifaximin (Drug)
norfloxacin
Arm 2: 109 patients will be treated with 400 mg of norfloxacin daily for 6 months.
干预措施: Norfloxacin (Drug)
结局指标
主要结局
Number of participants with recurrence of SBP
时间窗: 6 months
The total number of paper of participitants with recurrence of SBP
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Dr
Tanta University